Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury

NCT07436754 | Recruiting

• 2 other identifiers: Pro2025-0403HT94252510889
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to test two different training programs to find out which is better at helping people with a concussion or mild TBI (mTBI) improve their emotional health and well-being. Study participation is completely remote and will last approximately 8 months total, involving 4 assessment visits and 8 sessions of brain training via a secure video-conferencing platform. The 4 assessment visits (about 30-90 minutes each) include surveys and questionnaires about participant's emotional health. These assessment visits will take place before the training, immediately after the training, 3 months after training and 6 months after training. The 8 sessions of 1-on-1 training (about 60-90 minutes each) will be completed over the course of approximately 1 month.

Conditions

Mild Traumatic Brain Injury; Alexithymia

Keywords

Emotional dysregulation; Brain training; Concussion; Veterans; Military service members

Outcome Measures

Primary Outcomes (2)

• Toronto Alexithymia Scale-20

  his widely used alexithymia assessment (including the TBI population), is comprised of 3 factors: 1) ability to identify emotions); 2) ability to describe emotions; and 3) externally-oriented thinking. In addition to being a co-primary outcome measure, the TAS-20 scores will be used to determine eligibility (\>.5 SD above published means). It is a CDE and a PhenX toolkit measure has good psychometric properties, including good test-retest reliability. Range: Min/ Max = 20 to 100 Lower scores indicate less alexithymia (good); higher scores indicate greater alexithymia (bad)

  1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment.

• Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome)

  This commonly used measure of emotion dysregulation, uses a 5-point Likert scale, participants rate the frequency they utilize self-regulation behaviors in response to general emotional distress. Items are summed to provide a Total Emotion Dysregulation score. The DERS has high internal consistency, test-retest reliability, and good construct validity.56 Will be used to evaluate emotion dysregulation and to determine eligibility (\>.5 SD above published means). Range: Min/ Max = 36 to 180. Lower scores indicate less dysregulation (good); higher scores indicate more dysregulation (bad)

  1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months

Secondary Outcomes (6)

• Brief Resilience Scale (BRS)

  1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months

• Patient Health Questionnaire-9 (PHQ-9; depression)

  1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months

• PROMIS item banks for Anxiety

  1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months

• PROMIS item banks Anger

  1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months

• Post-traumatic Stress Checklist- 5 (PCL-5)

  1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months

Study Arms (2)

Program 1

EXPERIMENTAL

Enhance emotional awareness and ability to name, describe and express emotions with greater clarity, granularity and accuracy. Goals include enhancing participants' ability to: recognize and embrace the benefits of emotional awareness; detect onset of emotional responses early before escalation; accurately label and differentiate emotions; discern emotions from non-emotions; recognize and experience a larger breadth of emotions, including pleasant emotions.

Behavioral: Program 1

Program 2

ACTIVE COMPARATOR

To promote general wellbeing and quality of life. Grounded in Health Belief Model emphasizing self-management and self-efficacy. Content includes topics relevant to living health with a TBI Contents were derived from the Traumatic Brain Injury Model Systems Knowledge Translation Center factsheets and topics recommended by the Consumer advisory panel.

Behavioral: Program 2

Interventions

Program 1 BEHAVIORAL

Program 1 will teach participants how to recognize, label, and differentiate their emotions. The program will cover ways to reduce feeling "confused" or numb, and decrease the feelings of anger, stress and being overwhelmed.

Program 1

Program 2 BEHAVIORAL

Program 2 will teach participants strategies to improve their overall brain health and functioning. It will also teach participants how to develop and work towards individualized short-term and long-term goals aimed at improving their quality of life.

Program 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild TBI
• ≥18 years old
• ≥6 months post-TBI
• Elevated alexithymia and emotion dysregulation
• Capacity to consent
• Speaks and understands English
• Personal device capable of video conferencing and internet

You may not qualify if:

• Premorbid neurological disorder other than TBI
• Degenerative neurologic condition
• Active or uncontrolled major psychiatric disorder
• Conditions that pose safety concern to self or others, such as suicide risk
• Visual, hearing, communication, or cognitive impairments that would impede participation
• Unstable medications (e.g., started \< 6 weeks prior to enrollment) or anticipated medication changes that will influence mood/ affect during study participation
• Active involvement in an intensive rehabilitation program
• Individuals who recently started psychotherapy and/or mental health counseling (e.g., \<3 months prior)

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• United States Department of Defense: collaborator

Study Sites (3)

Indiana University

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

National Intrepid Center Of Excellence

Bethesda, Maryland, 20889, United States

NOT YET RECRUITING

Hackensack Meridian Health - JFK Johnson Rehabilitation Institute

Edison, New Jersey, 08820, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Affective Symptoms

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Behavioral Symptoms; Behavior

Study Officials

• Dawn Neumann, PhD, FACRM

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Wells

CONTACT

732-321-7000; grace.wells1@hmhn.org

Amanda Melton

CONTACT

317-408-5589; amamelto@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 27, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (3)